ISO 8536
ISO 8536:2022 is the international standard that specifies requirements for infusion equipment for medical use, including infusion bottles, infusion sets, injection parts, and fluid lines. These components are critical in clinical healthcare settings, and compliance with ISO 8536 ensures safety, sterility, and quality performance of medical infusion devices used in hospitals, clinics, and healthcare facilities.
At Quality Asia Certification, we offer ISO 8536 certification for manufacturers and suppliers of medical infusion equipment, demonstrating global compliance, enhancing product credibility, and ensuring safer healthcare delivery.
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What is ISO 8536?
ISO 8536:2022 is a multi-part standard series published by the International Organization for Standardization (ISO) that outlines specifications, dimensions, performance, and testing requirements for medical infusion and transfusion equipment. Key parts include:
- ISO 8536-1:2022 – Infusion bottles
- ISO 8536-4:2022 – Infusion sets for single use
- ISO 8536-6:2022 – Injection parts for containers
- ISO 8536-8:2022 – Infusion sets for single use with pressure infusion apparatus
These standards ensure compatibility, reduce risk of contamination, and align with international healthcare regulations and patient safety norms.
Why is ISO 8536 important?
ISO 8536 certification is vital for manufacturers of infusion and transfusion equipment aiming to:
- Comply with international health and safety norms
- Access regulated markets, including the EU, US, and Middle East
- Gain preference in government tenders and hospital procurement
- Demonstrate commitment to product sterility and patient safety
- Meet regulatory expectations from authorities like WHO, FDA, and CDSCO
With patient care and clinical reliability on the line, ISO 8536 compliance acts as a strong differentiator in the highly competitive medical device industry.
What are the benefits of ISO 8536?
- Assures standardized production of infusion-related medical equipment
- Promotes safe fluid delivery and transfusion procedures
- Enables compatibility and interchangeability of parts and accessories
- Supports infection control and sterility assurance
- Reduces product liability risks and compliance penalties
Certification also helps ensure that infusion products are robust, leak-proof, and meet the required flow rate, volume accuracy, and mechanical strength specifications.
What kind of businesses can benefit from ISO 8536?
Businesses that achieve ISO 8536:2022 certification gain several strategic and operational advantages:
✅ Market Access: Easier entry into international and regulated markets with recognized certification
✅ Brand Reputation: Establishes your brand as a quality-compliant medical device manufacturer
✅ Operational Excellence: Improved quality control, process validation, and regulatory alignment
✅ Tender & Export Eligibility: Strengthens eligibility for hospital tenders and healthcare exports
✅ Customer Confidence: Builds trust among healthcare buyers and clinical users
✅ Regulatory Alignment: Facilitates approvals under MDR, USFDA, CDSCO, and CE mark pathways
✅ Reduced Recalls & Complaints: Ensures high product performance and patient safety
Top Tips on making ISO 9001 effective for you.
#1
Top management commitment while practicing and accomplishing the standard is the key to success.
#2
Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.
#3
Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.
#4
Review systems, policies, processes, and procedures for a smooth working of QMS.
#5
Speaking to customers & suppliers while getting feedback & working on improvements.
#6
Training staff carrying out the internal audits with the opportunity for improvement.
#7
Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.
#8
Ensure continuous improvement by regularly reviewing and updating your quality management practices.
#9
Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.
Why QualityAsia?
QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:
Initial Certification – Stage 1 (Preparatory Phase)
- Thorough documented information review.
- Exchange of information with staff through online or onsite presence.
- Identification of key performances, processes & objectives as per the standard requisites.
- Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.
Initial Certification – Stage 2 (On-site Audit)
- Measurement, reporting & reviewing the performances against key performances objectives.
- Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
- Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
- Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.
Surveillance & Certification Renewal
Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.
